Job Summary

• The role involves leading the implementation of device development strategies and design controls for new and existing combination products from early concept to commercialization.
• Candidates must possess broad knowledge of U.S. and global medical device regulations including FDA cGMP, ISO 14971, and EN 62366 to ensure regulatory compliance.
• The position offers a competitive salary range of $142,400.00 to $224,100.00 along with comprehensive benefits including medical, dental, vision, and retirement plans.

Matching Summary

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Key Requirements

• B.A./B.S. in Mechanical, Biomedical, or Industrial Engineering
• Minimum 10 years of related experience
• Proven track record managing Design History Files (DHF)
• Subject matter expertise in medical device design controls
• Knowledge of FDA Human Factors guidance and ISO standards

Work Rights